A risk-based approach to validation. It is ultimately the responsibility of the sponsor to ensure that the outsourced electronic service is validated as appropriate. Sponsors should obtain documentation from the electronic service vendor that includes, but is not limited to, a description of SOPs and results of testing and validation.
This is particularly relevant for CROs providing services like data management and statistics. For this reason we write and maintain appropriate validation documentation and provide evidence of validation during audits and inspections as well as having adequately trained resources who understand the requirements of validation.